1. Field of the Invention
An object of the invention is electrophysiological diagnostic catheter especially for obtaining of endomyocardial biopsy of heart tissue, which is led and monitored using 3D electroanatomical mapping system.
The invention relates to diagnostic procedure of heart muscle biopsy (—endomyocardial biopsy—EMB), which is an invasive procedure giving a possibility to carry out morphological, immunohistological and structural examination.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 37 CFR 1.98
Heart muscle biopsy is performed in case of specific heart illnesses, such as unexplained congestive heart failure, sarcoidosis, amyloidosis, or storage diseases. An indication for biopsy is also a suspicion of neoplastic processes, giant-cell myocarditis, not responding to treatment and idiopathic acute heart failure, heart failure in individuals with cosinophilia, arrhythmia, suspicion of arrythmogenic cardiomyopathy, conduction disorders (especially II and III-degree atrioventricular block) and necessity of transplanted heart examination for possible rejection. During EMB there are taken 3 to 10 samples from the right or/and left ventricle.
From the state of the art there are devices known used in cardiology, which comprise elements enabling imaging, these are most often cameras or scanners or other devices used for detection or other devices including forceps.
From the application Nr. WO10102794A1 there are solutions known, which relate to the conducting diagnostic and/or therapeutic procedures, wherein a device comprises hollowed tube catheter for placement in vein or artery or other parts of body, wherein catheter is equipped with ending and imaging device is connected with catheter ending. Besides, the device comprises additional clearance or other tube elements around or in vicinity of catheter, through which guidewires, stents, balloons or other therapeutic modalities can be introduced, e.g. in order to examine or treat stenosis of coronary arteries or occlusions. Devices can also comprise biopsy pliers, an electrode catheter and mapping, ablative head or guidewires or any other device for usage in other diagnostic and/or therapeutic procedures.
From the US2008130965A application, there is a device known, comprising: a surgery device, having at least one or more sensors, wherein at least part of the sensors can detect orientation and location data, and at least a part can detect surgical parameters in situ. The surgical device includes at least one or more devices: an autonomous device, probe, guide, catheter, stimulator, aspirator, pliers, microscope, endoscope, and one or more implants.
Solutions from W008121143A1 relate to a catheter system with imaging possibilities to introduce a device into the desired location in patient's body. This catheter comprises inter alia an imaging scanner for imaging within whole patient's body, and an imaging reader, which is located inside and on distal ends of said elastic wire to enable imaging at least in one position.
From application Nr. RU2173091 a method of intravenous endomyocardial electrode catheter introduction is known, the system having bioptome installed on the end of catheter in order to examine and obtain tissue samples. Endomyocardial catheters and bioptome are designed as a cylinder of opposite spiral narrow fastening elements of crescent shape. The device is introduced to heart tissue, by rotating around its axis under electrographic control until moment of amplitude increases up to 70-120% in relation to its initial value and change in curve shape from two-phase to specific one-phase curves. Tissue samples are obtained by expanding of catheter-electrode. Thanks to that, it is possible to obtain tissue samples from different heart regions, even from the right ventricle.
There are also other devices known, in form of catheters capable of electroanatomic mapping, which most often additionally comprise ablation head, as described in the US2007287902A application, where a method of visual support in usage of electrophysiological catheter in heart is described, covering visualisation of 3D electroanatomical mapping, based on data delivered during usage of catheter of heart region which is intended for treatment, recording of 3D visual data from corpus region comprising region subjected to treatment using method of tomographic 3D imaging, separation of at least a significant part of region being treated based on 3D image and correlation and visualisation of data from 3D electroanatomical mapping and selection of 3D images next to each other in correct position and dimensions. Operators can also perform ablation treatment.
Despite development of tools for heart muscle biopsy (EMB), EMB diagnostic value is not satisfactory because of lack of targeted biopsy of pathological regions. Introduction of systems for a 3D electroanatomical mapping (3D-EAM) caused a possibility of creation of three-dimensional potential maps, which allow to identify heart regions with pathological electric function. EAM systems enable 3D EAM formation with mono- and bipolar potential map which reproduces region of borderline zone, scar and healthy muscle from the endocardium side and predicting potential pathological regions in a region of deeper myocardium and epicardium. Additional 3D mapping allows to define a conduction system and valve region, which can be linked with avoidance of performing biopsy from a conduction system surrounding/valve system and complications connected with that. Besides, EMB based on bioptome sampling from endocardium with amplitude <1.5 mV (scar or pathological fibrosis suspicion) can give crucial and more reliable information on pathological process in heart muscle and possibilities of further treatment. Especially important groups of patients are patients with cardiac arrhythmia and suspicion of myocarditis. EAM in those patient populations allows for performance of more precise biopsies from regions of disorders of electrophysiological heart muscle potentials. Up to now, EAM-EMB was based on the use of separate device for EAM and EMB. To create EAM map, mapping electrode was used and additionally biopsy specimen was introduced to EMB.